Process R&D
Turning promising chemistry into scalable manufacturing processes.
BioDuro’s Process R&D teams help transform early synthetic routes into practical, reproducible processes that are ready for scale-up. From route evaluation and process optimization to impurity control, safety assessment, and process characterization, we build the understanding needed to support IND-enabling development and downstream manufacturing.
Our teams support APIs, regulatory starting materials, intermediates, building blocks, and complex scaffolds, with analytical, process safety, and manufacturing capabilities available as programs advance.
Route Scouting & Evaluation
Evaluate existing and alternative synthetic routes with scalability and practical manufacturing in mind.
Capabilities may include:
- Route assessment and synthetic planning
- Evaluation of existing synthetic methods
- Identification of alternative route options
- Assessment of challenging reactions and complex molecules
- Selection of a practical route for further development
Process Optimization
Refine reaction and isolation conditions to improve process performance, consistency, and efficiency.
Capabilities may include:
- Reaction-condition screening
- Reagent and solvent evaluation
- Work-up optimization
- Isolation and purification development
- Short-path distillation
- Column purification
- Process reproducibility improvement
Process Characterization
Build a deeper understanding of how the process performs and where controls are needed before scale-up.
Capabilities may include:
- Impurity-profile development
- Impurity purge and fate studies
- Critical process parameter evaluation
- Process safety assessment
- Potential genotoxic impurity control
- Support for IND-enabling development
